Herbal law

  • Health
  • Sunday, 25 May 2003

Herbal Dilemmas 

THE regulation of herbal and nutritional supplements varies greatly, with some countries classifying them as food while others consider them as pharmaceuticals. Each nation’s approach is specific to its politics, history and culture.  

Herbal and nutritional supplements feature a broad range of numerous different food and medicinal products. The world market sales for herbal medicine products was estimated to be about U$60bil (RM228bil) in 2001, with the growth primarily fuelled by the hot segments such as menopause, energy, arthritis, sexual performance and sports nutrition. Top selling herbs are Ginkgo, Valerian and Echinacea.  

With so much at stake and so much diversity in regulation, there is a need for some form of control, at least in terms of quality and safety, if not efficacy.  

The US FDA focuses on current good manufacture practice (cGMP), effectively treating dietary supplements as foods.

US scenario 

On March 13, 2003, the FDA published a proposed rule on the current good manufacture practice (cGMP) for dietary supplements in the Federal Register. The purpose of the proposed rule is to establish standards necessary to ensure that dietary supplements are not adulterated with contaminants or impurities and are labelled accurately to reflect the active ingredients and other materials in the product.  

The proposed cGMP rule would require the use of new industry standards in the manufacturing, packaging, storage and distribution of dietary supplements, thus reducing the risks of contamination with harmful substances such as pesticides, heavy metals or other impurities.  

In addition, the proposal is intended to ensure that the identity, purity, quality, strength and composition of dietary supplements are accurately reflected on the product label which will assure the consumer that what they see is what they get.  

The proposed cGMP rule would require the manufacturers to: 

  • Employ qualified personnel.  

  • Design and construct the manufacturing facility to prevent contamination during manufacturing, packaging and storage.  

  • Use equipment and utensils of appropriate design and construction.  

  • Establish a quality control unit and appropriate manufacturing and packaging records.  

  • Store the raw materials, packaging materials and finished products under appropriate conditions of temperature, humidity and cleanliness to ensure their quality are not affected.  

  • Keep a written record of product complaints. 

  • Retain records for three years beyond the date of manufacture. 

    The proposed rule is intended to create a level playing field for the industry by ensuring that every firm uses high quality manufacturing processes and accurate labelling information. It does not address the safety of the ingredients or their effects on health.  

    The FDA is soliciting comments from the public and industry on how the proposed regulation could assist in accurate label information and prevent adulteration without undue burden to the industry. 

    European Union scenario 

    In Europe, the legislative environment has also been subjected to review with the national agencies of the 15 member states working towards harmonised regulatory rules for dietary supplements and herbal medicines in the European Union.  

    The first wave of legislation, the Vitamins and Minerals Directive, has already been adopted into European law and the focus now is on herbal medicines. While the US FDA has focused on cGMP, effectively treating dietary supplements as foods, the European Union’s proposed new legislation (Traditional Herbal Medicine Product Directive) issued in January 2002 is based on existing European pharmaceutical standards and legislation. 

    The current European pharmaceutical legislation is based on three pillars – proof of quality, safety and efficacy. The proposed legislation amends the third pillar, proof of efficacy, and replaces it with the need to prove only traditional use in relation to a specific condition. The first and second pillars, quality and safety, remain largely unchanged and will establish the standard for herbal products in the European Union. 

    The proposed legislation allows through a simplified registration procedure, the marketing of certain traditional medicinal products without requiring details of tests and trials on safety and efficacy, but on a history of safe use in the European community. The following eligibility criteria must be considered for herbal traditional medicinal products: 

  • The product is not harmful.  

  • Used solely for minor indications without intervention of a medical practitioner. 

  • Evidence of traditional use for 30 years in the European Union. 

  • Bibliographic report on safety with an expert report. 

  • Efficacy plausible on the basis of long-term use and experience. 

  • Product with specified strength. 

  • Applicable to herbal products for oral, external use or inhalation. 

    However, the quality requirement for the manufacture of herbal products is as demanding as for pharmaceutical GMP. The draft directive is now proceeding through the various legislative stages within the European Union. 

    Benefits of legislation 

    The legislation of herbal medicine, especially harmonised legislation of the various countries, provides many benefits to the industry as well as to consumers. The current stringent registration procedure for herbal medicines as pharmaceuticals in some countries will be reduced, thus removing the non-tariff barrier and allow wider access to the market.  

    For consumers, the safety and quality of such products are assured. In the long run, the market for herbal medicine products will be stabilised and promoted. 

    On the down side, the process of registration, formulation, stability testing, GMP, quality ingredients and validation data will have serious cost implications to the manufacturers, who will undoubtedly pass it on to the consumers.  


    It is gratifying to note that Malaysia, a small developing country, has already put in place the regulation of herbal medicine very much in line with the proposed Traditional Herbal Medicine Product Directive of the European Union.  

    Initiated in 1992, the requirement for the registration of traditional medicine and the GMP requirement for their manufacturing has enhanced the safety and quality of locally manufactured health supplements and placed Malaysia ahead of many of the developed countries in this area.  

    To maintain the standards for quality and safety of health supplements, continual and strict enforcement of the regulations by the Drug Control Authority is required. However, the onus of ensuring quality and safety rests even more with the manufacturers. The bigger challenge now is to harmonise the regulation of herbal medicine in the Asean region in view of the coming AFTA. 

    The regulation environment of herbal medicine in the world is in a state of flux. The development of new products or further development of existing natural products will be influenced by these regulations. Eventually only companies that have specialised knowledge and expertise in this sector can hope for success in the new environment. 

    Ref: Nutriceutical World, July/August 2002, April 2003 Herbal Medicine, Chaos In The Marketplace – Rowena K.Richter  

    The above article is contributed by Thomson’s panel of health professionals. For more information, e-mail starhealth@thestar.com.my  

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